Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer

Launched by SICHUAN UNIVERSITY · Mar 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for pancreatic cancer that combines a special vaccine designed to target cancer cells (called a neoantigen vaccine) with two other therapies: a medication called Anti-PD1 and chemotherapy. This combination will be tested in patients who have had surgery to remove their pancreatic cancer and are looking for additional treatment to help prevent the cancer from coming back. The main goal is to find out if this treatment is safe and effective for patients.

To be eligible for the trial, participants need to be between 18 and 75 years old and have a confirmed diagnosis of pancreatic ductal adenocarcinoma that has been surgically removed. They should be in good overall health and have no major uncontrolled health issues. During the study, participants will receive the new treatment and will be closely monitored for their health and any side effects. It’s important for potential participants to discuss this opportunity with their healthcare provider to see if it’s the right choice for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years and age ≤75 years.
• • 2. ECOG score 0-1.
• • 3. Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy.
• 4. Adequate bone marrow and organ function:
• • 5. Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
• • 6. Signed informed consent.
• • 7. Ability to comply with the study protocol and follow-up.
• Exclusion Criteria:
• • 1. Received antitumor chemotherapy, radiation therapy, or immunotherapy within 2 weeks prior to first vaccination.
• • 2. The patient has a history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or urothelial tumors (Ta and TIS), or other malignancies that have been treated with curative intent (at least 5 years prior to enrollment).
• • 3. Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, arrhythmias.
• • 4. HIV infection or active hepatitis B (HBV DNA≥500IU/ml), hepatitis C.
• • 5. Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions deemed ineligible by the investigator.
• • 6. Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, congestive heart failure, unstable angina, arrhythmias, etc;
• • 7. Patients with autoimmune diseases or immunodeficiencies being treated with immunosuppressive drugs.
• • 8. Pregnant or lactating women.
• • 9. Vaccination with other preventive vaccines within 4 weeks before the first administration or planned during the study period, including within 8 weeks after the last vaccination.
• • 10. Those who have had a severe allergic reaction to vaccines for other infectious diseases in the past.
• • 11. Those who may be allergic to the investigational product or any of its excipients.
• • 12. Substance abuse or inability to undergo immunotherapy due to clinical, psychological, or social factors.
• • 13. Significant weight loss (≥10%) within 6 weeks prior to enrollment.
• • 14. Any uncertain factors that may affect patient safety or compliance.